Merck KEYTRUDA Combo Advances in Bladder Cancer Treatment

Merck has secured a key step forward as the Merck KEYTRUDA FDA priority review gains momentum in bladder cancer treatment.

The US Food and Drug Administration has granted priority review for KEYTRUDA and KEYTRUDA QLEX, both evaluated in combination with Padcev. The applications target patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy.

The FDA has set a Prescription Drug User Fee Act target action date of August 17, 2026. If approved, the combination could become the first perioperative treatment option for MIBC across both cisplatin-eligible and ineligible patients, expanding beyond its current use limited to those unable to receive cisplatin.

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The Merck KEYTRUDA FDA priority review is backed by Phase 3 data from the KEYNOTE-B15 (EV-304) trial, developed in collaboration with Pfizer and Astellas Pharma. The results were recently presented at the ASCO Genitourinary Cancers Symposium, with plans for global regulatory submissions underway.

“Results from KEYNOTE-B15 challenge long-held expectations for patients with muscle-invasive bladder cancer,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.

“Even with curative-intent surgery and chemotherapy, patients still experience disease progression or limited survival. These data add to the growing body of evidence demonstrating that KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, have the potential to reshape how we approach treatment for these patients and improve outcomes for people facing this aggressive disease.”

Merck noted that the combination has now demonstrated overall survival benefits across three Phase 3 trials—KEYNOTE-B15, KEYNOTE-905, and KEYNOTE-A39. Additional late-stage studies are ongoing, exploring KEYTRUDA’s role across all stages of bladder cancer, from early disease to metastatic settings.